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FDA Updates for the Week of Jan. 9, 2023


The FDA has approved two medications: Rybelsus for first-line treatment of diabetes and asthma rescue combination medication. The agency has accepted an sNDA for Rexulti for Alzheimer’s agitation, and Eisai submits new Alzheimer’s drug for full approval.

FDA approves Rybelsus for first-line treatment of diabetes.

The FDA has approved a label update for Novo Nordisk’s Rybelsus (semaglutide) for use as a first-line treatment option for adults with type 2 diabetes. This update removes a previous limitation that it could not be used as the first therapy. Initially approved by the FDA in 2019, Rybelsus is the first and only GLP-1 analog in pill form and is indicated to improve glycemic control for adults with type 2 diabetes.

Rybelsus works to lower blood sugar in three ways: by increasing the release of insulin from the pancreas when blood sugar is high, decreasing the release of sugar from the liver, and slowing the process of food leaving the stomach after eating. Rybelsus comprises a unique co-formulation of semaglutide and an absorption enhancer called SNAC, which facilitates absorption of semaglutide in the stomach, making it possible to provide semaglutide as a pill.

The wholesale acquisition cost of Rybelsus is $935.77 for 30 tablets for either the 7 mg or 14 mg dose.

FDA approves rescue combination medication for asthma.

The FDA has approved Airsupra (albuterol/budesonide) as an as-needed treatment to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurized metered-dose inhaler combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid. It is being developed by AstraZeneca and Avillion.

In the United States, AstraZeneca will provide Airsupra to healthcare practitioners upon request for appropriate patients, and it will be commercially available in the first quarter of 2024, according to a company spokesperson.

AstraZeneca would not provide a list price, but the spokesperson said “the price of Airsupra in the U.S. reflects the value of the product, and as with all our medicines, we are committed to making sure that the patients who are prescribed our medicines have affordable access to them. When making any pricing decision, we aim to do so responsibly and in line with current treatment costs.”

FDA accepts sNDA for Rexulti for Alzheimer’s agitation.

The FDA has accepted a supplemental new drug application (sNDA) for Rexulti (brexpiprazole) for use in the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA has assigned the application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. The agency also indicated it is planning to hold a Psychopharmacologic Drug Advisory Committee meeting to discuss the application.

Agitation is a common symptom of Alzheimer’s dementia, reported in about 45% of patients.

Rexulti was discovered by Otsuka Pharmaceutical Company and is being co-developed by Otsuka and Lundbeck. It was approved in the United States on July 10, 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults.

Eisai/Biogen submit Alzheimer’s drug Leqembi for full approval.

Just after receiving accelerated approval for Leqembi (lecanemab-irmb) to treat patients with early Alzheimer’s disease, Eisai/Biogen have submitted a supplemental biologics license application (sBLA) for full approval. Leqembi is humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

The supplemental application is based on the data from the phase 3 confirmatory Clarity AD clinical trial. In Clarity AD, Leqembi met the primary endpoint and all key secondary endpoints with highly statistically significant results, and the profile of Amyloid-Related Imaging Abnormalities (ARIA) incidence was within expectations. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer's Disease (CTAD) conference, and also published in the Jan. 5, 2023, issue of The New England Journal of Medicine.

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